Cataract Lens Hardness Based on Phaco Tip Resistance

• Conditions: Cataract Senile

• Registration Number: NCT05110222
• Lead Sponsor: Ospedale Policlinico San Martino

Brief Summary

Phacoemulsificaton tip elongation depends upon voltage once resonant frequency of piezoelectric crystals has been reached.

Purpose of the study is to record voltage data of 20 consecutive cataract surgeries in order to evaluate correlation between voltage and LOCS classification of lens nuclei using a system that deploys a feedback mechanism capable of keeping invariant elongation regardless of enountered resistence

Detailed Description

The R-Evolution (Optikon 2000 Rome, Italy) phaco machine is equipped with a patented system named "minimal stress" that used the direct piezoelectric effect from the resonant ceramics that drive the phacoemulsificator tip to assess in real time and adjust phaco tip elongation that continuously varies according to encountered resistance.

After priming in balanced salt solution, phaco tip elongation and the amount of potential difference (voltage) needed to obtain a ginev elongation in balanced solution is assessed. Once the phaco tip is used during surgery, the resistence offered by the crystalline lens material to the phaco tip reduces actual elongaton which in turn reduces the voltage produced by the directo piezometric effect. The machine uses voltage produced by actual elongation to adjust the diving voltage and therefore can ensure accurate pahco tip elongation under any condition of lens material resistance.

Purpose of the study is to record driving voltage and its variations and evaluate if there is a correlation between phaco tip resistence and drving voltage.

This is evaluated both in vitro activating the phaco tip in increasingly dense glycerol solutions and in real life phaco surgery recording the voltage requested by phaco tip resistence and correlating it to the classification of lens opacity (LOCS III system) clinically used to grade cataract hardness.

Study Timeline

• Status Verified: 2021-09
• Study Start: 2021-09-01
• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2021-10-26
• Last Update Submitted: 2021-10-26
• Primary Completion: 2021-11-01
• Study First Posted: 2021-11-05
• Last Update Posted: 2021-11-05
• Study Completion: 2021-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

diagnosis of nuclear or cortical cataract

Exclusion Criteria

previous ocular trauma, previous ocular surgery, connective tissue disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cataract lens hardness according to LOCS III classification system	at enrolling	lens opacity and estimated nucleous hardness according to international LOCS classification
peak voltage	at the time of surgery	maximum voltage necessary to emulsify cataract nucleous
average voltage	at the time of surgery	voltage necessary to emulsify cataratct nuclous

Trial Locations

Locations (1)

IRCCS Policlinico San Martino; 🇮🇹 Genoa, Italy